Streetbeat News

Regulatory

JNJ

Janssen, a subsidiary of Johnson & Johnson (JNJ), has submitted a supplemental New Drug Application to the FDA for full approval of Balversa. The drug is intended for the treatment of patients with locally advanced or metastatic urothelial carcinoma and selected fibroblast growth factor receptor gene alterations.

Portfolio Pulse from Benzinga Newsdesk

August 28, 2023 | 8:16 pm

GLPG

Galapagos has announced the initiation of the GALACELA Phase 2 trial for Systemic Lupus Erythematosus (SLE) with GLPG3667. The first patient has been randomized in the trial.

Portfolio Pulse from Benzinga Newsdesk

August 28, 2023 | 8:16 pm

TRNR

Interactive Strength Inc has received a notice of delisting or failure to satisfy a continued listing rule or standard, leading to a transfer of listing from Nasdaq.

Portfolio Pulse from Happy Mohamed

August 28, 2023 | 8:15 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has been granted a US patent for its lead candidate EB-373, a psilocin prodrug under development for the treatment of anxiety disorder. The patent covers compositions and methods for tryptamine-derived prodrugs. The company believes these enhancements could provide a more rapid onset of action and reduced side effects compared to traditional psilocin prodrugs. Enveric is also advancing EVM201 and EVM301 series towards creating innovative alterations to related compounds for treating critical mental health disorders.

Portfolio Pulse from Lara Goldstein

August 28, 2023 | 8:08 pm

LIAN

LianBio has announced the results from its Phase 3 Explorer-CN trial of Mavacamten, which were presented at the European Society of Cardiology Congress and simultaneously published in JAMA Cardiology. The study confirms that the efficacy of Mavacamten can be extended to Chinese patients.

Portfolio Pulse from Happy Mohamed

August 28, 2023 | 8:06 pm

EWJ

SPY

The U.S. State Department has approved a potential sale of Joint Air-to-Surface Standoff Missiles to Japan, estimated at $104M, according to Reuters citing the Pentagon.

Portfolio Pulse from Benzinga Newsdesk

August 28, 2023 | 7:12 pm

TSLA

Tesla Inc (NASDAQ:TSLA) is preparing for two courtroom trials over fatalities involving its Autopilot system. The trials will scrutinize the safety of Tesla’s Autopilot technology and CEO Elon Musk’s role in its development and marketing. Tesla’s Autopilot system has been implicated in 736 accidents and 17 fatalities in the U.S. since 2019. The National Highway Traffic Safety Administration (NHTSA) has initiated investigations into several accidents. Tesla's shares are trading 0.28% lower.

Portfolio Pulse from AJ Fabino

August 28, 2023 | 7:11 pm

UTWO

The Federal Reserve's next move on interest rates remains uncertain, with Chair Jerome Powell's recent speech carrying both hawkish and dovish undertones. Money markets currently price in an 80% probability of the Fed keeping rates steady in September, but a 61% chance of a rate hike in November. The yield on the 2-year Treasury note, tracked by the U.S. Treasury Note ETF (NYSE:UTWO), surged above 5%. Key economic indicators to watch this week include the jobs report, inflation data, Q2 GDP 2nd estimate, and other data such as consumer confidence, mortgage rates, and manufacturing PMI.

Portfolio Pulse from Piero Cingari

August 28, 2023 | 7:06 pm

LEXX

Lexaria Biosciences has received a letter from NASDAQ confirming the cure of NASDAQ bid price deficiency, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

August 28, 2023 | 6:54 pm

AKBA

HC Wainwright has upgraded Akebia Therapeutics Inc (NASDAQ:AKBA) from Neutral to Buy rating. The company expects to resubmit its New Drug Application for vadadustat, a drug for anemia due to chronic kidney disease, by the end of Q3 2023. The resubmission includes additional safety data and new data from two alternate dosing studies. Analysts are highly confident in the FDA approval of vadadustat early next year. AKBA shares are up 23.9%.

Portfolio Pulse from Vandana Singh

August 28, 2023 | 6:31 pm